510(k) K153577
K153577 is an FDA 510(k) premarket notification submitted by Nanoentek USA, Inc. for the device "FREND Testosterone Test System". The FDA issued a decision of Substantially Equivalent on October 14, 2016. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Nanoentek USA, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 2016
- Date Received
- December 15, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device Class
- Class I
- Regulation Number
- 862.1680
- Review Panel
- CH
- Submission Type